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Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care

NCT06660719 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 852

Last updated 2025-03-07

No results posted yet for this study

Summary

This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient.

As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.

Conditions

Interventions

DRUG

SP-8203

SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)

DRUG

Placebo

Placebo will be intravenously administered twice daily (intervals of 12 hours)

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Jong Sung Kim, MD, Phd · GangNeung Asan Medical Center

  • Beom Jun Kim, MD, Phd · Seoul Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2027-03-30
Completion
2027-03-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660719 on ClinicalTrials.gov